Product code DRW— Cardiovascular

FDA has cleared 8 devices under product code DRW between 1976 and 2004, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20041 clearance
• 20021 clearance
• 19941 clearance
• 19871 clearance
• 19861 clearance
• 19852 clearances
• 19761 clearance

• Philips Medical Systems2 clearances
• Eaton Medical Group2 clearances
• Vital Signs, Inc.1 clearance
• Totemite Medical Electronics1 clearance
• Siemens Medical Solutions USA, Inc.1 clearance
• Physio-Control Corp.1 clearance

• K033513 — EASI ECG ALGORITHMPhilips Medical Systems·2004-01-15
• K020456 — EASI 12 LEAD ALGORITHMPhilips Medical Systems·2002-07-09
• K930786 — EPCORSiemens Medical Solutions USA, Inc.·1994-09-26
• K872781 — EASI LEAD SYSTEM CABLE ASSEMBLYTotemite Medical Electronics·1987-12-29
• K861981 — ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTORVital Signs, Inc.·1986-08-25
• K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTREaton Medical Group·1985-11-08
• K851632 — PCX-100 PATIENT INPUT LEADWIREEaton Medical Group·1985-11-08
• K761210 — LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)Physio-Control Corp.·1976-12-21